How Will Reforms Change the Landscape of China’s Clinical Trials?

China’s central government have introduced reforms in response to an increasingly challenging regulatory environment. These are likely to benefit medicine access as well as drug development, affecting those looking into China’s pharmaceutical market, which is the second largest in the world.

In a long-awaited response to feedback from the local and international pharmaceutical industry, the China State Council released “Opinions on Reforming the Review and Approval System for Drugs and Medical Devices” in 2015.[1]

Here, the government’s main priorities are for the China Food and Drug Administration (CFDA) to eliminate backlog of new drug applications, encourage research and improve the quality standards of generic drugs. Priorities also include encouraging new drug research and development, enhancing regulatory transparency, improving patent protection and improving the quality of the drug approval process.

As a result of this publication, the CFDA have changed legislation, reviews and recruitment to ensure the aforementioned priorities are met.

Moreover, in May this year, the CFDA announced four new areas to focus on in order to encourage innovation in drugs and medical devices. Though these are still under public consultation:

  • Product classification regulation
  • Clinical trial monitoring and audits
  • Review and approval policies
  • Action plan to enhance quality standards

Earlier on this year, the CFDA announced more changes to import drug registration requirements. This change is still under public consultation and outlines the reform of allowing and encouraging drugs developed elsewhere to hold clinical trials in China and outside China in parallel.

The CFDA have also opted for more reforms, including:

  • Shortening foreign drug registration by simplifying the process
  • Opening first in-human Phase 1 trials to global companies
  • Allowing applicants to make NDA submissions in China without the foreign country’s certificate of pharmaceutical product.

Shorter timelines and reduced backlog will help to boost clinical development in China for new drug companies as well as local innovators.

Overall, these reforms will help encourage new drug innovation in China, making it easier for those who wish to access the Chinese pharmaceutical market. At Client-Pharma, our in-depth knowledge of pharmaceutical markets means we provide efficient global clinical trial management in line with regulatory requirements, paired with the ability to source and supply pharmaceutical products globally. To find out more, contact us via email (info@client-pharma.com) or telephone (0044 1283 260054).

[1] http://www.gov.cn/zhengce/content/2015-08/18/content_10101.htm

August 2017